Carto 3 CB3434CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835003802), received between Sep 15, 2017 and Sep 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Read Input Signal” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K090017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2017Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) WITH TWO THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETERS, A CARTO 3 SYSTEM AND A CABLE AND SUFFERED PERICARDITIS REQUIRING HOSPITAL READMISSION. DURING THE PROCEDURE, A FORCE SENSOR ERROR POPULATED. SMARTTOUCH CATHETER # 1 WAS EXCHANGED FOR SMARTTOUCH CATHETER # 2 AND THE PROCEDURE CONTINUED. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THIS ERROR. DURING THE PROCEDURE, THERE WAS SIGNIFICANT SIGNAL INTERFERENCE OF BODY SURFACE AND INTRACARDIAC ELECTROCARDIOGRAMS (ECG) FOLLOWED BY THE LOSS OF ALL ECG SIGNALS. DURING THE SIGNAL INTERFERENCE, AN IMAGE WAS OBSERVED ON THE INTRACARDIAC ULTRASOUND THAT WAS SIMILAR TO THE IMAGE THAT APPEARS DURING ABLATION, BUT NO ABLATION WAS BEING PERFORMED. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE PERSISTED. UPON DISCONNECTING THE CATHETER CABLE, THE ISSUE WAS RESOLVED. CATHETER CABLE WAS REPLACED AND THE PROCEDURE CONTINUED. POST-PROCEDURE, THE PATIENT DEVELOPED SEVERE PERICARDITIS. SINCE THERE WERE NO MEDICAL ISSUES APPARENT DURING ABLATION, THE TEAM IS ATTRIBUTING THE SYMPTOMS TO A POSSIBLE CURRENT LEAKAGE RELATED TO THE CATHETER CABLE, PROCEDURE R

  Patient problems: Inflammation

  MAUDE report 6869842 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090017. One submission often covers many models, so check the product and lot details in each record.

• Z-1230-2012 · Feb 9, 2012 · Terminated
  CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
• Z-1839-2011 · Feb 15, 2011 · Terminated
  10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole ca
• Z-0884-2011 · Oct 5, 2010 · Terminated
  CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster ele
• Z-2369-2012 · Nov 17, 2009 · Terminated
  CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a